EP2916826A4 - Ultra low density pulmonary powders - Google Patents

Ultra low density pulmonary powders

Info

Publication number: EP2916826A4
Authority: EP; European Patent Office
Prior art keywords: low density; ultra low; powders; pulmonary powders; density pulmonary
Prior art date: 2012-11-09
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Granted

Application number

EP13852608.2A

Other languages

German (de)

French (fr)

Other versions

EP2916826B1 (en

EP2916826A1 (en

Inventor

Michael M Lipp

Richard P Batycky

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Civitas Therapeutics Inc

Original Assignee

Civitas Therapeutics Inc

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2012-11-09

Filing date

2013-11-08

Publication date

2016-07-27

2012-11-16 Priority claimed from US13/679,245 external-priority patent/US8545878B1/en

2013-11-08 Application filed by Civitas Therapeutics Inc filed Critical Civitas Therapeutics Inc

2013-11-08 Priority to EP21170515.7A priority Critical patent/EP3957301A1/en

2015-09-16 Publication of EP2916826A1 publication Critical patent/EP2916826A1/en

2016-07-27 Publication of EP2916826A4 publication Critical patent/EP2916826A4/en

2021-04-28 Application granted granted Critical

2021-04-28 Publication of EP2916826B1 publication Critical patent/EP2916826B1/en

Status Active legal-status Critical Current

2033-11-08 Anticipated expiration legal-status Critical

Links

239000000843 powder Substances 0.000 title 1
230000002685 pulmonary effect Effects 0.000 title 1

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
- A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
- A61J3/074—Filling capsules; Related operations
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B1/04—Methods of, or means for, filling the material into the containers or receptacles
- B65B1/16—Methods of, or means for, filling the material into the containers or receptacles by pneumatic means, e.g. by suction
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B1/20—Reducing volume of filled material
- B65B1/26—Reducing volume of filled material by pneumatic means, e.g. suction
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B1/30—Devices or methods for controlling or determining the quantity or quality or the material fed or filled
- B65B1/36—Devices or methods for controlling or determining the quantity or quality or the material fed or filled by volumetric devices or methods
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B63/00—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
- B65B63/02—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for compressing or compacting articles or materials prior to wrapping or insertion in containers or receptacles
- B65B63/028—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for compressing or compacting articles or materials prior to wrapping or insertion in containers or receptacles by pneumatic means

Landscapes

Health & Medical Sciences (AREA)
Engineering & Computer Science (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Medicinal Chemistry (AREA)
Bioinformatics & Cheminformatics (AREA)
Epidemiology (AREA)
Mechanical Engineering (AREA)
Pulmonology (AREA)
Neurosurgery (AREA)
Neurology (AREA)
Biomedical Technology (AREA)
Inorganic Chemistry (AREA)
Otolaryngology (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Biophysics (AREA)
Molecular Biology (AREA)
Psychology (AREA)
Quality & Reliability (AREA)
Dispersion Chemistry (AREA)
Emergency Medicine (AREA)
Medicinal Preparation (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Basic Packing Technique (AREA)
Medical Preparation Storing Or Oral Administration Devices (AREA)
Oil, Petroleum & Natural Gas (AREA)

EP13852608.2A 2012-11-09 2013-11-08 Ultra low density pulmonary powders Active EP2916826B1 (en)

Priority Applications (1)

Application Number	Priority Date	Filing Date	Title
EP21170515.7A EP3957301A1 (en)	2012-11-09	2013-11-08	Ultra low density pulmonary powders

Applications Claiming Priority (7)

Application Number	Priority Date	Filing Date	Title
US201261724781P	2012-11-09	2012-11-09
US13/679,245 US8545878B1 (en)	2012-11-09	2012-11-16	Capsules containing high doses of levodopa for pulmonary use
US13/945,160 US8685442B1 (en)	2012-11-09	2013-07-18	Capsules containing high doses of levodopa for pulmonary use
US201361884315P	2013-09-30	2013-09-30
US201361884319P	2013-09-30	2013-09-30
US201361884436P	2013-09-30	2013-09-30
PCT/US2013/069107 WO2014074797A1 (en)	2012-11-09	2013-11-06	Ultra low density pulmonary powders

Related Child Applications (1)

Application Number	Title	Priority Date	Filing Date
EP21170515.7A Division EP3957301A1 (en)	2012-11-09	2013-11-08	Ultra low density pulmonary powders

Publications (3)

Publication Number	Publication Date
EP2916826A1 EP2916826A1 (en)	2015-09-16
EP2916826A4 true EP2916826A4 (en)	2016-07-27
EP2916826B1 EP2916826B1 (en)	2021-04-28

Family

ID=50685169

Family Applications (5)

Application Number	Title	Priority Date	Filing Date
EP13852608.2A Active EP2916826B1 (en)	2012-11-09	2013-11-08	Ultra low density pulmonary powders
EP21170515.7A Pending EP3957301A1 (en)	2012-11-09	2013-11-08	Ultra low density pulmonary powders
EP13853467.2A Active EP2925611B1 (en)	2012-11-09	2013-11-08	Dosator for filling a capsule with powder
EP13852876.5A Active EP2916821B1 (en)	2012-11-09	2013-11-08	High dose levodopa capsules for pulmonary use
EP20202500.3A Pending EP3815679A1 (en)	2012-11-09	2013-11-08	High dose levodopa capsules for pulmonary use

Family Applications After (4)

Application Number	Title	Priority Date	Filing Date
EP21170515.7A Pending EP3957301A1 (en)	2012-11-09	2013-11-08	Ultra low density pulmonary powders
EP13853467.2A Active EP2925611B1 (en)	2012-11-09	2013-11-08	Dosator for filling a capsule with powder
EP13852876.5A Active EP2916821B1 (en)	2012-11-09	2013-11-08	High dose levodopa capsules for pulmonary use
EP20202500.3A Pending EP3815679A1 (en)	2012-11-09	2013-11-08	High dose levodopa capsules for pulmonary use

Country Status (19)

Country	Link
US (3)	US9539211B2 (en)
EP (5)	EP2916826B1 (en)
JP (6)	JP6836834B2 (en)
KR (6)	KR102257164B1 (en)
CN (4)	CN104918607B (en)
AU (6)	AU2013342248B2 (en)
BR (2)	BR112015010601B1 (en)
CA (3)	CA2890459C (en)
DK (1)	DK2916821T3 (en)
ES (2)	ES2880271T3 (en)
HK (5)	HK1212884A1 (en)
MX (3)	MX2015005767A (en)
NZ (4)	NZ708684A (en)
PL (1)	PL2916821T3 (en)
PT (1)	PT2916821T (en)
RU (2)	RU2670987C2 (en)
SG (5)	SG10202109328QA (en)
WO (3)	WO2014074797A1 (en)
ZA (2)	ZA201504058B (en)

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WO2014074797A1 (en) *	2012-11-09	2014-05-15	Civitas Therapeutics, Inc.	Ultra low density pulmonary powders
MA40910A (en) *	2014-11-07	2017-09-12	Civitas Therapeutics Inc	RAPAMYCIN POWDERS FOR PULMONARY ADMINISTRATION
KR101748796B1 (en) *	2015-09-30	2017-06-19	한미약품 주식회사	Inhalation capsule with enhanced delivery rate of active ingredients
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WO2019060797A1 (en)	2017-09-22	2019-03-28	Teva Branded Pharmaceutical Products R&D, Inc.	Method for manufacture of inhalation powders
WO2019067708A1 (en)	2017-09-27	2019-04-04	Teva Branded Pharmaceutical Products R&D, Inc.	Method for particle size reduction
PL3833964T3 (en)	2018-08-07	2023-09-04	Norton (Waterford) Limited	Application of raman spectroscopy for the manufacture of inhalation powders
EP3608015B1 (en) *	2018-08-08	2021-10-06	Harro Höfliger Verpackungsmaschinen GmbH	Powder provision device for a powder metering apparatus
CN108995838A (en) *	2018-09-10	2018-12-14	江西克莱威纳米碳材料有限公司	A kind of powder tinning system
CN109178367B (en) *	2018-10-15	2021-01-26	楚天科技股份有限公司	Filling head and filling device for powder split charging
CN110040519A (en) *	2019-04-30	2019-07-23	裕东（中山）机械工程有限公司	A kind of quantitatively Dual-Phrase Distribution of Gas olid conveying device and dose delivery system
RU2716294C1 (en) *	2019-10-04	2020-03-11	Владимир Александрович Трусов	Tandem reflecting furnace for aluminum scrap remelting
IT202000008962A1 (en) *	2020-04-24	2021-10-24	Romaco Srl	EQUIPMENT FOR FILLING CONTAINERS WITH A POWDER MATERIAL
CN116546980A (en) *	2020-12-11	2023-08-04	江苏恒瑞医药股份有限公司	Pharmaceutical composition for pulmonary delivery

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AU2018222983A1 (en)	2018-09-20
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SG11201503547TA (en)	2015-06-29
JP6347786B2 (en)	2018-06-27
CN109106697B (en)	2022-02-15
AU2017279626A1 (en)	2018-01-18
HK1213186A1 (en)	2016-06-30
RU2670987C2 (en)	2018-10-29
US20180036253A1 (en)	2018-02-08
KR20210062730A (en)	2021-05-31
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AU2013342246A1 (en)	2015-07-02
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